Events

Alerta De Seguridad para HeartStart MRx monitor/defibrillator

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Philips Healthcare.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-03-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120321d.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Field safety notice: philips heartstart mrx monitor/defibrillator medical device manufacturer, philips healthcare, has issued a customer information letter concerning heartstart mrx monitor/defibrillator, models m3535a, m3536a, m3536m, m3536mc, m3536m2, m3536m4,m3536m5, m3536m6. according to philips, the heartstart mrx instructions for use (ifu) have been improved to better clarify c02/etc02 measurements taken by the mrx devices with software versions f.02, r.02, 9.Xx or earlier versions. an addendum to the ifu has been issued. according to the local supplier, the affected devices were distributed to hong kong. the customer information letter and the ifu addendum will be sent to all affected customers. if you are in possession of the products, please contact your supplier for necessary actions.

Device

HeartStart MRx monitor/defibrillator
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips HeartStart MRx monitor/defibrillator
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH